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PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)

NCT01320254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2017-10-12

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of panitumumab plus cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract cancer patients without systemic pre-treatment, compared to the historical data and to the randomised control group without the antibody, which verifies the historically based assumption.

Conditions

  • Cholangiocarcinomas

Interventions

DRUG

Cisplatin, Gemcitabine, Panitumumab

Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8 Panitumumab 9mg/kg BW at day 1

DRUG

Cisplatin, Gemcitabine

Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Arndt Vogel, PD Dr. MD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-09-12
Completion
2016-09-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320254 on ClinicalTrials.gov